Inflatable penile prostheses (or, as may be termed hereinafter, “IPPs”) are well known and have been in wide use. These devices are surgically implanted in male patients who, typically, are unable to achieve or sustain a penile erection due to a physical disability.
IPPs typically comprise several components such as a fluid reservoir, a pump, a valve, at least one inflatable cylinder, and various lengths of tubing which fluidly connect the fluid reservoir, the pump, the valve, and the inflatable cylinder or cylinders (hereinafter, whether singular or plural, “cylinder”). Typically the fluid reservoir is surgically implanted in the patient's abdomen, with the pump and the inflatable cylinder being surgically implanted in, respectively, the patient's scrotum and penile corpora cavernosa; and the valve is commonly co-located with the scrotal pump. After implantation and in use, when an erection is desired by the patient, the scrotal pump is typically manipulated by the patient in an instructed way to cause fluid transfer from the reservoir, via the valve, to the cylinder such that inflation of the cylinder is effected thereby resulting in an erection as desired. When the patient desires to terminate the erection and return his penis to a flaccid state, the scrotal pump is typically again manipulated by the patient in an instructed way to cause fluid transfer from the cylinder, via the valve, back to the reservoir such that deflation of the cylinder is effected thereby resulting in penile flaccidity as desired. For further reference, an example of a known IPP is described in U.S. Pat. No. 4,566,446 to Fogarty, titled “Penile Prosthesis Device.”
Known IPPs heretofore have presented several drawbacks to physicians who implant them in patients, and also to the patients themselves. Among these deficiencies are, for example: (i) an unmet need for a reservoir containing a larger fluid volume than known reservoirs, (ii) difficulty in collapsing and folding, or otherwise manipulating, known reservoirs for placement in a patient's abdomen during implantation surgery, (iii) an unmet need for a cylinder containing a larger fluid volume than known cylinders, and (iv) difficulty in collapsing and folding, or otherwise manipulating, known cylinders for placement in a patient's corpora cavernosa during implantation surgery.
Attempts have been made to solve these aforementioned deficiencies with respect to IPP reservoirs through construction of relatively larger spherical or cylindrical elongate reservoirs of generally standard geometric shapes or cross-sections such as, e.g., spherical and cylindrical. An example of such a known reservoir is shown in U.S. Pat. Applic. Pub. No. 2005/0113639 of George, et al., titled “Fluid Reservoirs for Penile Implant Devices and Methods of Manufacturing.”
Attempts have also been made to solve the aforementioned deficiencies with respect to IPP cylinders through construction of relatively larger elongate cylinders, analogously to the known reservoirs mentioned above.
Thus, there exists a need for implantable fluid devices that may overcome deficiencies of known devices. In particular, for example, such implantable fluid devices may provide increased fluid volume in an IPP system without increased outer dimensions or an overall profile of the reservoir or cylinder relative to known reservoirs or cylinders. Also, such implantable fluid devices may be easier to surgically implant relative to known reservoirs and cylinders. Thus, these implantable fluid devices of the present invention may allow a physician to more easily collapse and fold them for insertion into the patient's anatomy while affording a greater range of fluid volume compared to known devices. To accomplish these objectives, these implantable fluid devices could be constructed with a novel and heretofore unknown geometric shape or cross-section that increases surface area when inflated or filled, thereby increasing a total available volume. Thus, these implantable fluid devices could accommodate a larger fluid volume than known devices without requiring a larger elongate or cross-sectional area or “footprint”; and these devices could also require relatively less manipulation to fold and insert into the patient's anatomy thereby making surgical implantation procedures faster and more efficient than possible with known implantable fluid devices.
It is to be understood that collectively throughout this description, IPP reservoirs and cylinders are generally termed “implantable fluid devices” although the term is not limited to such reservoirs and cylinders and could include other implantable devices involving fluid containment, exchange, or transfer. Thus, novel aspects of the present invention regarding implantable fluid devices per se will be appreciated by those in the surgical arts to be capable of use in, and beneficial to, virtually any implantable fluid devices—even those outside of IPP technologies.